SleepmateCannula Oral/Nasal, Case of 25 814320-000/25

GUDID 05707480041855

Ref. 14867, Industry Standard CO2

Ambu A/S

Polysomnograph
Primary Device ID05707480041855
NIH Device Record Keyf235c918-7d05-4f38-922b-47a189f7ba0f
Commercial Distribution Discontinuation2019-02-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSleepmateCannula Oral/Nasal, Case of 25
Version Model Number814320-000/25
Catalog Number814320-000/25
Company DUNS305682023
Company NameAmbu A/S
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480041855 [Primary]
GS105707480133994 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZQMonitor, breathing frequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-08
Device Publish Date2016-09-21

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